State Service of Ukraine on Medicines suspends licenses of 24 companies after quality checks
9 April 10:21
In the first quarter of 2025, the State Administration of Ukraine on Medicines and Drugs Control conducted more than 200 inspections in the field of medicines circulation. As a result of the violations identified, the circulation of eight drug names was banned, and 24 business entities had their licenses suspended. This is reported by "Komersant Ukrainian" with reference to the press service of the Ministry of Health.
As a reminder, starting from January 1, 2025, the State Administration of Ukraine on Medicines and Drugs resumed scheduled inspections of the requirements of the legislation on the quality of medicines and compliance with license conditions in the pharmaceutical market and in the field of drug trafficking.
In the first quarter of 2025, the State Service on Medicines and Drugs Control of Ukraine (SMDC ) conducted a large-scale inspection of the pharmaceutical market. More than 200 inspections were carried out in various sectors, including:
- 129 inspections concerned quality control of medicinal products;
- 105 – production, wholesale, retail and import of medicinal products.
Considerable attention was paid to compliance with license conditions, product quality and patient safety.
The most common violations: from human resources to drugs
The inspections revealed not only minor technical deficiencies, but also systemic problems in the work of pharmaceutical institutions:
- Understaffing: many pharmacies operate without a sufficient number of pharmacists with proper education and qualifications.
- Quality problems: lack of effective quality management systems at the enterprises.
- Record-keepingviolations: medical institutions have failed to comply with the requirements for the storage and documentation of narcotic substances.
- Illegal sales: prescription drugs were sold without prescriptions, and in some cases, expired drugs or drugs without instructions were sold.
Minister of Health Viktor Lyashko emphasized:
“Prescription medicines should be sold exclusively on prescription, and this should be done by a specialist – a pharmacist. Instead, we see that not all pharmacies are provided with qualified personnel. This threatens the quality of pharmaceutical services and patient safety. I instruct the State Administration of Ukraine on Medicines and Drugs Control to analyze the situation within a week and provide proposals for the effective launch and functioning of the pharmacists’ register.”
Consequences of inspections: bans and fines
The results of the inspections were serious:
- 8 names of medicinal products were banned from circulation due to the violations found.
- Licenses of 24 business entities were suspended.
- For violations in the circulation of narcotic and psychotropic substances, 8 letters with signs of criminal offenses were sent to law enforcement agencies.
Regarding market surveillance:
- 234 inspections of product characteristics were conducted.
- Fines amounting to UAH 765 thousand were imposed, of which UAH 510 thousand have already been paid to the state budget.
- We received 18 decisions to suspend customs clearance of products.
